Actively Recruiting
Real-world Experience With the Castor Single Branch Stent Graft in the Management of Acute Aortic Syndrome
Led by First Affiliated Hospital Xi'an Jiaotong University · Updated on 2023-07-28
205
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
F
First Affiliated Hospital Xi'an Jiaotong University
Lead Sponsor
H
Hanzhong Central Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of the Castor single branch stent graft for treating patients with acute aortic syndrome who have an inadequate proximal landing zone less than 15 mm. This observational, ambispective, multicenter cohort study focuses on those who underwent thoracic endovascular aortic repair with this device between June 2018 and June 2022. The study includes 205 patients who received the Castor single branch stent graft. Patients had follow-up visits at 1 month, 6 months, and 1 year after the procedure for physical exams, laboratory tests, and CT angiography assessments. They will continue returning for follow-ups at 2 years, 3 years, and annually up to 10 years to monitor their condition and the performance of the stent graft. Participants will undergo evaluations including imaging scans to track aortic remodeling, check for adverse events related to the device or procedure, and monitor for any need for re-intervention. The main outcomes measured are immediate success of the procedure, mortality, and major complications within 1 year, along with ongoing long-term safety and effectiveness. The total follow-up duration can extend up to 10 years post-procedure.
CONDITIONS
Brief Title
Evaluation of the Castor Single Branch Stent Graft in Treatment of Acute Aortic Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with acute Stanford type B aortic syndrome
- Received thoracic endovascular aortic repair with the Castor single branch stent graft between June 2018 and June 2022
You will not qualify if you...
- Patients with acute type B aortic syndrome who have an adequate proximal landing zone (≥15 mm)
- Previous endovascular repair of the aorta
- Patients with missing data or loss of follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Procedure occurred between June 2018 and June 2022
Participants who received thoracic endovascular aortic repair with the Castor single branch stent graft are included in the study.
1 procedure visit
Duration - Up to 10 years post-procedure
Participants undergo routine follow-up visits for assessment including physical examinations, laboratory tests, and CT angiography to monitor safety and efficacy.
Follow-up visits at 1 month, 6 months, 1 year, 2 years, 3 years, and annually up to 10 years
Trial Site Locations
Total: 1 location
1
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China, 710061
Actively Recruiting
Research Team
H
Hongyan Tian, MD
M
Mengyang Kang, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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